MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-10 for SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK MOL2150 NA manufactured by Focus Diagnostics.
[40119090]
Focus diagnostics has received a total of 34 complaints from 20 customers for early cycle threshold (ct) issues with the direct amplification disc (dad) (mol1455, mol1451, and mol 1452) while performing the (b)(4) direct assay. This error may result in a (b)(6) result, and error code(s) giving an invalid run. Early internal testing reproduced the early ct threshold; however, these early ct were produced only when the dad was used after a previous partial run. The false result was not reported to the doctor. There was no patient involvement. A voluntary recall has been performed related to the reported lot. As of (b)(6) 2016, there has been no report of patient injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023365-2016-00031 |
| MDR Report Key | 5493882 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-10 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-11 |
| Date Added to Maude | 2016-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS VALERIE CIMMARUSTI |
| Manufacturer Street | 11331 VALLEY VIEW STREET |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 5622406484 |
| Manufacturer G1 | FOCUS DIAGNOSTICS |
| Manufacturer Street | 11331 VALLEY VIEW STREET |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90630 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK |
| Generic Name | HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY |
| Product Code | OQO |
| Date Received | 2016-03-10 |
| Model Number | MOL2150 |
| Catalog Number | NA |
| Lot Number | 29813 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAGNOSTICS |
| Manufacturer Address | 11331 VALLEY VIEW STREET CYPRESS CA 90630 US 90630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-10 |